CARMAT Obtained Approval to Proceed with First Human Implantations of Its Total Artificial Heart
These institutions are the St Pierre University Hospital (Brussels, Belgium), the Silesian Center for Heart Disease (Zabrze, Poland), the Prince Sultan Cardiac Center (Riyadh, Saudi Arabia), and the University Medical Centre Ljubljana (Ljubljana, Slovenia).
All these institutions share excellence in surgical results and heart patient care, depth of patient recruitment and experience in innovative medical devices pre-market clinical trials.
In a common statement, Prof. Didier de Cannière, Chief of the Department of Cardiac Surgery at St Pierre University Hospital in Brussels, Belgium, Prof. Marian Zembala, Chairman, Department of Cardiac Surgery and Transplantation and Director of the Silesian Center for Heart Diseases in Zabrze, Poland, Prof. Borut Geršak, Head of the Department of Cardiovascular Surgery at the Ljubljana University Medical Centre, in Ljubljana, Slovenia, and Prof. Antonio Calafiore, Head of the Department of Adult Cardiac Surgery at Prince Sultan Cardiac Center in Riyadh, Saudi Arabia, declared: “We are very glad to share our experience and knowledge and thus contribute to this extraordinary project, as end-stage heart failure is indeed an international health issue. CARMAT’s bioprosthetic artificial heart could bring true innovation to the heart failure surgical community and we are looking forward to starting its implantation and to exploring its potential benefits for our patients.”
Prof. Alain Carpentier, co-founder and Scientific Director at CARMAT, comments: "I have been very pleased to learn that the leaders of these prestigious departments are willing to join us in the evaluation of the Carmat bioprosthesis. As recognized experts in the field, they will be able to appreciate first-hand the unique features and remarkable performances of this prosthesis."
Marcello Conviti, CEO of CARMAT, concludes: “The patient selection process and the training of the clinical teams are ongoing in these four countries, supported by our French proctors, Prof. Christian Latrémouille, Cardiac Surgeon at the Georges Pompidou European Hospital in Paris and Prof. Daniel Duveau, Medical Director of the Thorax Institute and of the Department of Thoracic and Vascular surgery at University Hospital in Nantes. Implantations could start shortly following the completion of the training. Carmat expects to receive additional approvals in a near future, potentially in France (ANSM approval) and in other countries.”
Published on : Thu, 16 May 2013
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